(65 days)
Not Found
No
The device description and intended use focus on mechanical morcellation and suction, with no mention of AI or ML capabilities.
Yes.
The device is explicitly indicated for "therapy" in two contexts: "for therapy via the transurethral passage after a TURP (TransUrethral Resection of the Prostate) procedure" and "for diagnosis and therapy of urolithiasis." It is used for the cutting and removal of tissue masses, and disintegration and removal/aspiration of kidney and bladder stones, which are therapeutic actions.
Yes
When used as a nephroscope, the device is explicitly stated to be used for "diagnosis and therapy of urolithiasis."
No
The device description clearly outlines multiple hardware components including an endoscope, rotary blade, sheaths, obturators, a motor, a generator, and a suction pump.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The described devices (Morce Scope Set, Power Control, Suction Pump) are used for surgical procedures involving the cutting, removal, and aspiration of tissue and stones within the body. They are tools for performing a physical intervention, not for analyzing samples outside the body to diagnose or monitor a condition.
- Intended Use: The intended uses clearly state procedures like morcellation, disintegration and removal of stones, and aspiration of fluid during endoscopic operations. These are all therapeutic or diagnostic procedures performed directly on the patient.
- Lack of Specimen Analysis: There is no mention of the devices being used to analyze tissue or fluid samples in vitro to provide diagnostic information.
Therefore, the Morce Scope Set, Power Control 2303, and Suction Pump 2207 are considered surgical devices or endoscopic accessories, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Morce Scope Set 8970:
The Morce Scope Set, in conjunction with a morcellation probe, and with its sheaths and obturators, is used in the cutting (morcellation) and continuous removal of large detached tissue masses.
In combination with intracorporeal lithotriptors, e.g. operated pneumatically, by ultrasound, electro-hydraulically or by laser under endoscopic control, it can be used as a nephroscope in the disintegration and removal/aspiration of kidney and bladder stones and the removal of detached tumors from the bladder.
Power Control 2303:
The POWER CONTROL 2303 in conjunction with POWER STICK M4 serves to drive WOLF morcellators for the continuous removal of ablated tissue in endoscopic operations.
Suction Pump 2207:
The SUCTION PUMP is used for aspirating irrigation fluid in conjunction with a resectoscope or a morcellator following laser TURP.
Indication and Field of Use:
When used as a Morce Scope: for therapy via the transurethral passage after a TURP (TransUrethral Resection of the Prostate) procedure.
When used as a nephroscope: for diagnosis and therapy of urolithiasis.
In both cases the product must be used in conjunction with endoscopic accessories. The product may only be applied by adequately qualified and trained medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
78 FJL, 79 GEY and JCX
Device Description
The Morce Scope Set 8970, is a morcellation set that consist of a Morce endoscope, rotary blade, sheaths, obturators and an optional sieve. The rotary blade is designed to be rotaly blade, arreather sendoscope, requiring one incision. The rotary blades are driven by infortou the the merco on the Power Controlled by the Power Control Generator 2303. The suction pump 2207 removes the morcellated tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The product may only be applied by adequately qualified and trained medical personnel.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The devices are designed to meet the standards IEC601-11 1988 and A1 + A2 and IEC601-1-2.
No clinical tests performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K970105, K030082, K011911, K982515
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
AUG 1 9 2004
K041610
Page 1 of 3
Image /page/0/Picture/2 description: The image shows the logo for Richard Wolf Medical Instruments Corporation. The logo features the words "RICHARD WOLF" in bold, black letters. To the right of the text is a square graphic containing a stylized image of a wolf.
353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com
13.0 510(k) Summary of Safety and Effectiveness
| Submitter: | |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | IL 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | June 4, 2004 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | ( 847 ) 913 1113 |
| FAX number (include area code): | ( 847 ) 913 0924 |
Product Information:
| Trade name: | Morce Scope Set with Power Control 2303 and Suction Pump 2207 |
|---|---|
| Model number: | 2303.011/.901/.911, 8564.121/.851 |
| Common name: | Motorized Morcellator Endoscope Set with Suction Pump |
| Classification name: | Resectoscope, Endoscope and accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
|---|---|---|---|
| 1 K970105 | 1 RIWO CUT Morcellator | 1 Richard Wolf | |
| 2 K030082 | 2 Power Control 2303 with Power Stick M4 | 2 Richard Wolf | |
| 3 K011911 | 3 Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories | 3 Richard Wolf | |
| 4 K982515 | 4 Power Drive Modell #7688PD | 4 WISAP, Germany | |
| 5 | 5 VersaCut | 5 Coherent |
1.0 Description
The Morce Scope Set 8970, is a morcellation set that consist of a Morce endoscope, rotary blade, sheaths, obturators and an optional sieve. The rotary blade is designed to be rotaly blade, arreather sendoscope, requiring one incision. The rotary blades are driven by infortou the the merco on the Power Controlled by the Power Control Generator 2303. The suction pump 2207 removes the morcellated tissue.
1
Intended Use 2.0
Intended USe
Morce Scope Set 8970, in conjunction with a morcellation probe, and with its sheaths and Morce Scope Set 6970, in Conjunction with a mercemations removal of large tissue masses.
In combination with the corresponding auxiliary instruments, it can be used as a In combination with the coresponding adxillary instration of kidney and bladder stones and nephroscope in the disintegration and rollioners of transurethral (bladder) passages, in tife removal of tumors via peroductions (Kians, ) , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , electro-hydraulically or by laser, under endoscopic control.
The POWER CONTROL 2303 in conjunction with POWER STICK M4 serves to drive The POWER CONTROL 2000 in ochjanction will .
WOLF morcellators for the continuous removal of ablated tissue in endoscopic operations.
The SUCTION PUMP is used for aspirating irrigation fluid in conjunction with a resectoscope or a morcellator following laser TURP.
Technological Characteristics 3.0
Technological Characteristics
The rotary blade consists of an outer blade and a rotating inner blade with sharp toothed The rotaly braue contaneous suction is possible through the inner blade.
The tissue intended for morcellation must be separated prior by laser or other techniques in the submitted Morce Scope Set as it is in the previous morcellation systems.
The POWER CONTROL 2303 is operated with motor handle POWER STICKS M4 that rives the rotary blade clock-wise, counter-clockwise or in oscillation mode when the corresponding foot pedal or front panel button is depressed
The Suction Pump 2207 is a roller pump that generates a continuous vacuum. The suction rate is limited to a preselectable value and is controlled by a flow detector.
Via the CAN-BUS interface, the POWER CONTROL 2303 and the Suction pump 2207 can via the OAN BOO mondoo, the NO NET SYSTEM with remote control, speech control, or touch-screen monitor.
Substantial Equivalence 4.0
The submitted devices pose the same type of questions about safety or effectiveness as r the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-devices sold by Richard Wolf, Coherent and WISAP.
5.0 Performance Data
r enormance Data
The devices are designed to meet the standards IEC601-11 1988 and A1 + A2 and IEC601-1-2.
6.0 Clinical Tests
No clinical tests performed.
2
Conclusions Drawn 7.0
By:
Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
Robert J. Casarsa
Robert L. Casarsa Quality Assurance Manager
Date: June 4, 2004
RICHARD MEDICAL INSTRUMENT
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2004
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway VERNON HILLS IL 60061
Re: K041610
Trade/Device Name: Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: 78 FJL; 79 GEY and JCX Dated: June 4, 2004 Received: June 22, 2004
Dear Mr. Casarsa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about ar to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometion Free (110) warket the device, subject to the general controls provisions of the Act. The r ou may, ateres provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dry has made a aved regulations administered by other Federal agencies. You must or any I oderal bataloo and roginements, including, but not limited to: registration and listing eonfpry with an the rive on (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), and mig (QS) regulation (21 CFR Part 820); and if applicable, the electronic rond in the adiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket nothication - The PDA inding of sassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you desire specific advice for your declose on one of the following numbers, based on the regulation number at the top of the letter.
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, Tor questions on the promotion in a semation entitled, "Misbranding Othice of Compliance at (301) 37 1 1057. Part 807.97) you may obtain. Other general by reference to premarket notification (DTCF Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 63-2041 or Manthacturers, International and Octosenhttp://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
5.0 INDICATIONS FOR USE
| 510(k) Number (if known): | K041610 |
|---|---|
| Device Name: | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 |
| Intended use: | Morce Scope Set 8970: |
| The Morce Scope Set, in conjunction with a morcellation probe, and with its sheaths and obturators, is used in the cutting (morcellation) and continuous removal of large detached tissue masses. | |
| In combination with intracorporeal lithotriptors, e.g. operated pneumatically, by ultrasound, electro-hydraulically or by laser under endoscopic control, it can be used as a nephroscope in the disintegration and removal/aspiration of kidney and bladder stones and the removal of detached tumors from the bladder. | |
| Power Control 2303: | |
| The POWER CONTROL 2303 in conjunction with POWER STICK M4 serves to drive WOLF morcellators for the continuous removal of ablated tissue in endoscopic operations. | |
| Suction Pump 2207: | |
| The SUCTION PUMP is used for aspirating irrigation fluid in conjunction with a resectoscope or a morcellator following laser TURP. | |
| Indication and Field of Use: | |
| When used as a Morce Scope: for therapy via the transurethral passage after a TURP (TransUrethral Resection of the Prostate) procedure. | |
| When used as a nephroscope: for diagnosis and therapy of urolithiasis. | |
| In both cases the product must be used in conjunction with endoscopic accessories. The product may only be applied by adequately qualified and trained medical personnel. | |
| Revised 8/18/04 | |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) |
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use
Per 21 CFR 801.109
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devi
510(k) Number
OR
Over-The Counter __
5-1
(Optional Format 1'2-96)